Email Worksheet SUBJECT: #VALUE! BODY: #VALUE! Prinng Instrucons (Please print the following parts of the work For Drug Registraon (excludin For Non-Drug Registraon (excludin For Licensing (exclusin Applicaon Process Overview The applicaon form has six parts: 1) General Informaon, 2) Establishment Informaon, 3) Product Informaon, 4) Supporng Informaon, 5) Sources and Clients, and 6) Applicant Informaon. In the worksheet 'Form' (with the red tab) you will see a dashboard where the different parts are idenfied. If the part is appropriately filled up, a green 'PROCEED' will be indicated.Required fields will appear sequenally.To minimize errors and confusion, it is recommended that a blank form be used for every applicaon. If the form is appropriately filled up, the composed body text (in the green box) will appear. Be careful to paste the body text completely as text (not as an image or as an aachment). DON'T aach any file to the email request.
Transcript
Email WorksheetSUBJECT: #VALUE!
BODY: #VALUE!
Printing Instructions (Please print the following parts of the worksheet 'Form' if applicable)
For Drug Registration (excluding amendments and compliances):For Non-Drug Registration (excluding amendments and compliances):
For Licensing (exclusing amendments and compliances):For All Other Applications:
Application Process Overview
The application form has six parts: 1) General Information, 2) Establishment Information, 3) Product Information, 4) Supporting Information, 5) Sources and Clients, and 6) Applicant Information. In the worksheet 'Form' (with the red tab) you will see a dashboard where the different parts are identified. If the part is appropriately filled up, a green 'PROCEED' will be indicated.Required fields will appear sequentially.To minimize errors and confusion, it is recommended that a blank form be used for every application. If the form is appropriately filled up, the composed body text (in the green box) will appear. Be careful to paste the body text completely as text (not as an image or as an attachment). DON'T attach any file to the email request.
#VALUE!IMPORTANT
READ THIS PAGE CAREFULLY.
#VALUE!
Printing Instructions (Please print the following parts of the worksheet 'Form' if applicable)
For Drug Registration (excluding amendments and compliances): pages 1 and 4.For Non-Drug Registration (excluding amendments and compliances): pages 1 and 3.
For Licensing (exclusing amendments and compliances): pages 1 and 2.For All Other Applications: page 1 only.
Application Process Overview
Provide information only when asked for.
APPLICATION FORM 5 SOURCES & CLIENTS #VALUE!
Document Tracking Number APPLICATION FORM STATUSGENERAL INFORMATION: #VALUE!
3.4.1 For Drug Product Format: Presentation 1 (GPIN 1)/ Presentation 2 (GPIN 2)/ … Presentation n (GPIN n) Example: 150mL (01234567891011)/ 90 mL (01234567891012)
CLOPIDOGREL (as BISULFATE)Off-white to beige, semi biconvex film-coated tablet with score on one side and plain on the other side
Provide in this space a description of the product in terms of rheology, thermal, and geometry properties among others, as applicable; Indicate if appropriate microbiological cultures present in the product
Use this space to explain how the lot code used on the product label is correctly interpreted
CLOPIDOGREL (AS BISULFATE) NINBO BEITONG IMP. & EXP. CO. LTD., INDIA KAMAGONG CHEMTRADE CORP./SAN PEDRO LAGUNA2) Active Pharmaceutical Ingredient; 2) API Manufacturer, Address Address Address; 2) API Supplier, Address Address Address;3) Active Pharmaceutical Ingredient; 3) API Manufacturer, Address Address Address; 3) API Supplier, Address Address Address;4) Active Pharmaceutical Ingredient; 4) API Manufacturer, Address Address Address; 4) API Supplier, Address Address Address;5) Active Pharmaceutical Ingredient; 5) API Manufacturer, Address Address Address; 5) API Supplier, Address Address Address;6) Active Pharmaceutical Ingredient; 6) API Manufacturer, Address Address Address; 6) API Supplier, Address Address Address;7) Active Pharmaceutical Ingredient; 7) API Manufacturer, Address Address Address; 7) API Supplier, Address Address Address;8) Active Pharmaceutical Ingredient; 8) API Manufacturer, Address Address Address; 8) API Supplier, Address Address Address;9) Active Pharmaceutical Ingredient; 9) API Manufacturer, Address Address Address; 9) API Supplier, Address Address Address;10) Active Pharmaceutical Ingredient; 10) API Manufacturer, Address Address Address; 10) API Supplier, Address Address Address;11) Active Pharmaceutical Ingredient; 11) API Manufacturer, Address Address Address; 11) API Supplier, Address Address Address;12) Active Pharmaceutical Ingredient; 12) API Manufacturer, Address Address Address; 12) API Supplier, Address Address Address;
Department of Health Food and Drug Administration APPLICATION FORM
Initial INT 1RenewaRNW 0AutomatARNVariatioVARAmendmAMD Major MaVCompliaCOM Minor MiVRe-Issu REIReappli RAPHome SolHSO Other OTHSales P SPR FinishedFIPDiscounDSC Raw MatRAWAmendmeAMJ Activity ACTAmendmAMN Product PRLGenericGLE NothingNOFFree SalCFS ReclassiRCLPharmacePHPExport CEXP Major MaVBrand NBRN Minor - MiV-PA1 to 20ProvisioPPM Minor - MiV-PA1 to 20, PH01 to PH06ExemptioCEX Minor - MiV-N
